SMILE - TTT: Surgical MIcrovascularization of Lower Extremities for Diabetic Foot Ulcers - Transverse Tibial Transport Study
Biodynamik, Inc
Summary
The purpose of this study is to evaluate the safety and clinical performance of transverse tibial bone transport in patients with chronic ischemic and diabetic lower extremity ulcers. This study will assess wound healing outcomes and limb preservation in a population with limited therapeutic alternatives.
Description
Diabetic lower extremity ulcers are associated with impaired blood flow, delayed wound healing, high morbidity, and an increased risk of limb loss. In some patients, conventional treatments such as wound care, revascularization procedures, or adjunctive therapies are ineffective or not feasible, leaving limited options short of major amputation. Transverse tibial bone transport (TTT) is a surgical technique that applies controlled distraction to the tibial cortex and has been reported in prior clinical studies to stimulate angiogenesis, improve local perfusion, and support wound healing in is…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults (\>=22 years). * Chronic diabetic foot ulcer wound persisting \>=12 weeks and less than 104 weeks refractory to standard wound care. * Wound location within distal 1/3 tibia and below including foot. * Wound stages: WiFi \>= 3 * At least one patent lower extremity tibial vessel (after revascularization if needed). * Able to provide informed consent and comply with study procedures. Exclusion Criteria: * Active systemic infection (positive blood cultures) * Severe sepsis (2 out of 4 SIRS criteria with impact on organ dysfunction) * Subacute lower extremity wound…
Interventions
- DeviceBiodynamik XT3
Application of XT3 system and transverse tibial bone transport procedure
Location
- Mayo ClinicJacksonville, Florida